BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MCGHAN

    MDR report key: 292288 · Received August 22, 2000

    Report

    Report Number
    MW1019747
    Event Type
    Injury
    Date Received
    August 22, 2000
    Date of Event
    January 28, 2000
    Report Date
    August 15, 2000
    Manufacturer
    MCGHAN
    Product Code
    FTR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    "S/P L MRM FOR STAGE I BREAST CA & R MRM FOR STAGE I BREAST CA. PT IS NED. L BREAST WAS RECONSTRUCTED WITH A TRAM FLAP & R WITH AN EXPANDER & IMPLANT WITH LOWER SKIN ADVANCEMENT WITH FLAP. HAS A MCGHAN TRIPLE LUMEN 500/560 TO 620CC & STATES THAT THE SALINE RUPTURED. NO H/O TRAUMA AS PT LOST 1 CUP SIZE OVERNIGHT, IT IS INCREASINGLY FIRM & MORE PAINFUL IN RECENT YEARS. PT ALSO C/O R LAT AX FAT FOLD DESPITE LS TO THE AREA. IN ADDITION, C/O PROGRESSIVE SYSTEMIC SX'S. HAS ARTHRALGIAS/MYALGIAS (+ AM STIFFNESS), PARESTHESIAS, SPASMS, FATIGUE, SLEEP DISTURB, L HI CX ADENOPATHY, LO GRADE FEVERS, HOT FLASHES/SWEATS, HA'S, TMJD, VISUAL CHANGES, DIZZINESS, MEMORY LOSS, SICCA, HAIR LOSS, ORAL SORES, RASHES, SENS SUN/CHEM, CP, CHOKING SENS, INCREASED CHOLESTEROL, WGT GAIN, GI/GU DISTURB, & EASY BRUISING. PT IS OTHERWISE HEALTHY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MCGHAN TRIPLE LUMEN FTR MCGHAN NA DV9606

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other| S